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Diagnostic Relevance of Salivary Testosterone Concentrations in Doping Control.

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ClinicalTrials.gov Identifier: NCT02134470
Recruitment Status : Unknown
Verified April 2015 by Dr. Martin Schoenfelder, Paracelsus Medical University.
Recruitment status was:  Active, not recruiting
First Posted : May 9, 2014
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Dr. Martin Schoenfelder, Paracelsus Medical University

Brief Summary:
It is generally accepted that chemical testing of biologic fluids is the most objective means of diagnosis of drug use. In recent years saliva has attracted much attention. The prime advantage of saliva is that it offers non-invasive, stress-free and real-time repeated sampling whereas blood collection is undesirable, difficult and expensive. In addition, it is known that androgens such as testosterone can be assayed in saliva, as these steroids pass the endothelial-epithelial barriers by passive diffusion. Nevertheless, the correlations of blood, urine and saliva concentrations are not well documented. In recent reviews, it is pointed out that salivary hormone analysis could be a promising method for sports medicine and doping control, but much work is needed before the use of saliva samples in this area receives the acceptance. According to recent studies the increase of testosterone concentration in saliva is significantly higher than alterations of steroid concentrations (or ratios) in blood or urine. Saliva concentration may therefore serve as screening parameter to select suspicious cases for further target evaluation (e.g. by IRMS). This may be beneficial to identify cases of transdermal administration of low steroid doses. It is therefore the aim of the present project to detect administered testosterone in saliva and compare these levels to those in blood and urine. The intention is not to detect high dosage but low dosage abuse of testosterone, as a single-dose by patch application. From the practical point of view saliva could offer a complementary specimen for a pre-screening of testosterone. So it could be assumed that salivary testosterone exceed upon plasma and/or urine levels. So the present study could be the base for a new method to preselect the suspicious samples for testosterone abuse.

Condition or disease Intervention/treatment Phase
Circadian Exercise Testosterone Drug: Testosterone supplementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diagnostic Relevance of Salivary Testosterone Concentrations After Exogene Low-dose Hormone Application as a Screening Method for in Doping Control.
Study Start Date : April 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Testosterone
Chemical testing of saliva is an objective method to quantify steroid hormones. Recent studies indicate that salivary testosterone is significantly higher than in other body fluids. Therefore, saliva may serve as pre-screening parameter to select suspicious cases for further target evaluation. The aim of the present project is to detect administered testosterone in saliva and compare these levels to those in blood and urine. Therefore, each participant represents its own control.
Drug: Testosterone supplementation
Low-dose testosterone supplementation will be facilitated by using hormone patches. For pharmacokinetic aspects circadian profiles of saliva/blood/urine will be measured under native conditions and under exogene hormone application. In addition, cross-reactivity of a standardized exercise bout and hormone application will be of further interest.




Primary Outcome Measures :
  1. Salivary testosterone concentration [ Time Frame: 2 weeks ]
    Salivary testosterone concentration will be quantified in relation to circadian time, exercise, and external low-dose hormone application.


Secondary Outcome Measures :
  1. Serum testosterone [ Time Frame: 2 weeks ]
    Serum testosterone concentration (free/bound) will be quantified in relation to circadian time, exercise, and external low-dose hormone application.

  2. Circulating microRNA in blood plasma [ Time Frame: 2 weeks ]
    Circulating microRNA in blood plasma will be screened in relation to circadian time, exercise, and external low-dose hormone application.


Other Outcome Measures:
  1. Testosterone in hairs [ Time Frame: 4 weeks ]
    At onset, 2 weeks and 4 weeks after testosterone application steroid hormone concentration will be quantified in scalp hair.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male
  • healthy
  • informed consent

Exclusion Criteria:

  • any metabolic, cardiovascular, pulmonary disorder
  • neoplastic or hormonal disorders
  • active sports competitor
  • disorders which hinder cycling ergometry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134470


Locations
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Germany
Technische Universität München
Munich, Bavaria, Germany, 80809
Sponsors and Collaborators
Paracelsus Medical University
Technische Universität München
Investigators
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Principal Investigator: Martin Schönfelder, Dr. Paracelsus Medical Private University Salzburg, AUT
Principal Investigator: Hande Hofmann, Dr. Technische Universität München, GER
Principal Investigator: Detlef Thieme, Dr. Institute of Doping Analysis und Sports Biochemistry Dresden in Kreischa, GER
Additional Information:
Publications:
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Responsible Party: Dr. Martin Schoenfelder, Head of Institute, Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT02134470    
Other Study ID Numbers: BISP-SALIVA-2014
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015
Keywords provided by Dr. Martin Schoenfelder, Paracelsus Medical University:
saliva
blood
urine
Additional relevant MeSH terms:
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Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs